US20060271107A1

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Publication number: US20060271107A1
Application number: US11/431,416
Authority: US
Inventors: Michael Harrison; Richard Fecther; Arthur Moran
Original assignee: Individual
Current assignee: University of California
Priority date: 2004-09-29
Filing date: 2006-05-09
Publication date: 2006-11-30

Abstract

Systems and methods for auto-anastomosing a region occupying one or more hollow viscera of the body are disclosed. The system includes a first magnetic member configured to be delivered to a location in the body adjacent the region. A second magnetic member is configured to be located adjacent the region opposite from the first magnetic member such that said region is disposed in between the first magnetic member and the second magnetic member. The first and second magnetic members are configured to generate an attractive force to compress tissue in the region between them so that the tissue in the region necroses as a result of the compressive force such that tissue surrounding the necrosed tissue heals together to form an anastomosis. The anstomosis may connect a fistula between two internal viscera or viscera segments, or create a stoma from a viscera to an external surface of the body.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of copending application Ser. No. 10/954,995 filed on Sep. 29, 2004, incorporated herein by reference in its entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC

Not Applicable

NOTICE OF MATERIAL SUBJECT TO COPYRIGHT PROTECTION

A portion of the material in this patent document is subject to copyright protection under the copyright laws of the United States and of other countries. The owner of the copyright rights has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the United States Patent and Trademark Office publicly available file or records, but otherwise reserves all copyright rights whatsoever. The copyright owner does not hereby waive any of its rights to have this patent document maintained in secrecy, including without limitation its rights pursuant to 37 C.F.R. § 1.14.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention pertains generally to apparatus and methods for magnetically manipulating body structures and more particularly to performing corrective procedures on a patient via incremental magnetic loading.

2. Description of Related Art

Anatomical deformities occur in the general populous in a number of different forms and from a variety of causes. Examples of skeletal deformities include, pectus excavatum, scoliosis, club feet, and numerous forms of skeletal dysplasia. These conditions are treated in a variety of different manners from braces to surgery, with sometimes minimal efficacy.

The defect known as pectus excavatum, or funnel chest, is a congenital anomaly of the anterior chest wall. The excavatum defect is characterized by a deep depression of the sternum, usually involving the lower half or two thirds of the sternum, with the most recessed or deepest area at the junction of the chest and the abdomen. The lower 4-6 costal or rib cartilages dip backward abnormally to increase the deformity or depression and push the sternum posterior or backward toward the spine. Also, in many of these deformities, the sternum is asymmetric or it courses to the right or left in this depression. In many instances, the depression is on the right side.

Pectus excavatum with significant deformity occurs in approximately 1 out of every 2000 births. The deformity may be present at birth but is often noted after several years of age and usually worsens during rapid growth around puberty. Because of the pressure of the sternum and cartilages, defect also pushes the midline structures so that the lungs are compressed from side to side and the heart (right ventricle) is compressed. Severe lesions have a major effect on thoracic volume and pulmonary function but the principal motivation for repair is the deformity itself. It does occur in families and thus, is inherited in many instances. Other problems, especially in the muscle and skeletal system, also may accompany this defect. In approximately ⅕ of the patients, scoliosis is present. The regression or any improvement in this defect rarely occurs because of the fixation of the cartilages and the ligaments. When one takes a deep breath or inspires, the defect is usually accentuated.

Pectus excavatum can be repaired surgically using an open approach in which the malformed costal cartilages are resected and the sternum forcibly held in place with a metal strut. In another approach, described in U.S. Pat. No. 6,024,759, the sternum is forced into a corrected position often under great tension, and held in place with a metal strut. Both can achieve good results but at the cost of considerable morbidity: an operation under general anesthesia followed by a 4-7 day hospital stay required for pain control usually by continuous epidural analgesia. Several more weeks of moderate to severe discomfort are typical and complications from the sternum held forcibly against the metal strut are not infrequent. It is necessary to leave the bar in place for a year or more before it is removed in another procedure. Total cost usually reimbursed by third party payers averages more than $30,000.

The problem with all currently available pectus excavatum surgical repairs is that they attempt to achieve immediate total correction and fixation often under considerable tension. A better approach would be the gradual step-by-step correction of the deformity by applying a smaller force over a longer period of time.

Another skeletal deformity, scoliosis, is a condition in which an individual has an abnormal spine curvature. Generally, some curvature in the neck, upper trunk and lower trunk is normal. However, when there are abnormal side-to-side (lateral) curves in the spinal column, the patient is generally diagnosed as having as scoliosis.

Orthopaedic braces are typically used to prevent further spinal deformity in children with curve magnitudes within the range of 25 to 40 degrees. If these children already have curvatures of these magnitudes and still have a substantial amount of skeletal growth left, then bracing is a viable option. The intent of bracing, however, is to prevent further deformity, and is generally not used to correct the existing curvature or to make the curve disappear.

Surgery is an option used primarily for severe scoliosis (curves greater than 45 degrees) or for curves that do not respond to bracing. The two primary goals for surgery are to stop a curve from progressing during adult life and to diminish spinal deformity.

Although there are different techniques and methods used today for scoliosis surgery, all of them involve fairly invasive procedures with considerable patient morbidity. One frequently performed surgery involves posterior spinal fusion with instrumentation and bone grafting, which is performed through the patient's back. During this surgery, the surgeon attaches a metal rod to each side of the patient's spine by anchor's attached to the vertebral bodies. The spine is then fused with a bone graft. The operation usually takes several hours and the patient is typically hospitalized for a week or more. Most patients are not able to return to school or for several weeks after the surgery and cannot perform some pre-operative activities for up to four to six months.

Another surgery option for scoliosis is an anterior approach, wherein the surgery is conducted through the chest walls instead of entering through the patient's back. During this procedure, the surgeon makes incisions in the patient's side, deflates the lung and removes a rib in order to reach the spine. The anterior spinal approach generally has quicker patient rehabilitation, but usually requires bracing for several months after this surgery.

Yet another medical practice in need of improvement is anstosmosis of organs, i.e. creating an opening between two normally separate anatomical regions or organs. Anastomosing hollow organs together is a mainstay of surgery: vascular anastomosis, intestinal anastomosis, urinary tract anastomosis are common procedures in the medical practice. Restoring continuity to hollow viscera has been a fertile realm for surgeons, and numerous techniques have evolved in attempt to make these connections work. The most commonly used are suture anastomosis or stapled anastomosis. However, these techniques tend to be highly invasive and result in significant morbidity.

For these reasons, it would be desirable to provide improved apparatus and methods for repositioning bone structures, by applying a corrective force to the bone structure, which could be gradually adjusted much like orthodontic tooth braces.

It would be further desirable to provide a device that applies a corrective force to reposition a body member without a mechanical force that requires piercing of the skin, thereby limiting the specter of infection and wound problems.

In addition, it would be desirable to provide a device for repositioning bones structures having tension-sensing technology to allow measurement of the force applied to correct all types of asymmetric deformities and allow protection of skin against pressure damage.

It would further be desirable to provide improved devices and methods for minimally invasively treating pectus excavatum.

In addition, it would be desirable to provide improved devices and methods for minimally invasively treating scoliosis.

At least some of these objectives will be met with the inventions described hereinafter.

BRIEF SUMMARY OF THE INVENTION

The present invention comprises apparatus and methods for altering the position, orientation, growth or development of body parts and organs by magnetic forces to apply a steady sustained force over time. The invention uses magnetic force fields that may be used to correct a number of anatomic deformities, including, but not limited to: pectum excavetum, pectus carinatum, scoliosis, club feet, cranial/facial anomalies or defects, skeletal dysplasias, cartilaginous deformities/dysphasia, and joint deformities/dysphasia. The invention may also be used to incrementally lengthen bone or apply bone compression to promote healing.

An aspect of the invention is an apparatus for incrementally manipulating an internal body member of a patient. In one embodiment, the apparatus comprises magnetic implant adapted to be received on a location of the body member, a platform external to the patient, and a magnetic member coupled to the platform, wherein the magnetic member generates a magnetic force between the implant and the platform to incrementally manipulate the body member. The implant and external magnetic member preferably comprise a rare earth magnet or array of rare earth magnets, and are configured to generate an attractive or repulsive force between the implant and the platform to reposition, reorient, deform, or lengthen the body member.

In one aspect of the invention, the implant is adapted to be received on a location of the sternum to treat pectus excavatum. In this configuration the platform comprises a chest plate adapted to be positioned exterior to the patient's chest. The magnetic member is coupled to the chest plate to generate an attractive force between the implant and the chest plate to incrementally reposition the sternum.

The implant is preferably adapted to be received on a posterior surface on the sternum. The implant generally comprises an internal magnet and a casing to enclose the internal magnet. The casing may be made from any rigid biocompatible material capable of withstanding the forces of the magnet without significant deformation, such as high-grade medical epoxy or similar material used in the art.

In a preferred embodiment, the implant is attached to the sternum using a plurality of sutures, wherein the sutures are looped through a plurality of holes in the implant casing and around the sternum to attach the implant to the posterior surface of the sternum.

In one embodiment, the platform chest plate generally has a concave inner surface to allow the sternum to deform outwardly from the chest. The platform may also have an adjustable stage coupled to the chest plate, wherein the magnetic member is mounted on the stage. A plurality of adjustment members may be coupled to the stage to adjust the orientation and position of the magnetic member with the implant.

In another embodiment of the invention, a plurality of sensors and a strain gauge may be coupled to the chest plate, with the strain gauge measuring the force applied to one or more locations on the platform.

In most cases the attractive force of the magnets support the chest plate to the patient's chest. However, a chest strap may also be used to support the chest plate to the patient's chest.

In another aspect of the invention, the implant is adapted to be received on a location of a vertebrae of the patient's spine to treat scoliosis or other spinal disorders. In this configuration, the platform comprises a support adapted to be positioned exterior to the patient's torso. Generally, the magnetic member is coupled to the support such that the magnetic member generates a magnetic force between the implant and the plate to incrementally reposition the spine. The magnetic member and the implant may be configured to generate an attractive or repulsive force between the implant and the magnetic member.

Where the patient has an abnormal curvature of the spine, the implant is preferably configured to be received on a vertebrae located at an apex of the abnormal curvature. The support may be positioned such that the magnetic force incrementally repositions the spine to remove the abnormal curvature. The implant and the magnetic member may also be configured to impart a torsional force on the vertebrae to incrementally reorient the spine.

In one embodiment, a bone screw is threaded into the vertebrae to rigidly couple the implant to the vertebrae.

According to another aspect of the invention, a method for incrementally repositioning an internal body member of a patient comprises installing a magnetically responsive implant to a location on the internal body member; positioning a platform exterior the patient to generate a magnetic field, the magnetic field effecting an magnetic force between the implant and the platform, and manipulating the body member to a first state as a result of the generated magnetic force.

In a preferred embodiment, the method also includes adjusting the magnetic field to one or more intermediate settings, manipulating the body member to one or more intermediate state as a result of the attractive force generated by the one or more adjusted magnetic field settings, adjusting the magnetic field to a final setting; and manipulating the body member to a final state as a result of the attractive force generated by the final magnetic field setting.

The step of generating a magnetic field may comprise generating an attractive or repulsive force between the implant and the platform. The body member may be manipulated by repositioning the body member to a first position, deforming the body member to a first shape, or lengthening the body member to a first length. Repositioning the sternum may comprise deforming one or more cartilages connected to the sternum as a result of the attractive force, or deforming the shape of the sternum as a result of the attractive force.

In one aspect of the invention, manipulating a body member comprises manipulating the patient's sternum. In such a configuration, installing a magnetically responsive implant comprises attaching an internal magnet to a posterior location on the sternum. Positioning a platform is achieved by manipulating a stage housing an external magnet, the stage being coupled to a chest plate. A plurality of adjustment members may be used to adjust the position and orientation of the external magnet with respect to the internal magnet, thereby effecting the magnitude and direction of the magnetic force between the platform and the implant.

In one aspect of the invention, manipulating a body member comprises manipulating a vertebrae of the patient. In such a configuration, installing a magnetically responsive implant comprises attaching an internal magnet to a location on the vertebrae. The vertebrae may be manipulated by adjusting the magnetic field between the implant and the platform to incrementally reposition the spine. The magnetic field may be adjusted to generate an attractive or repulsive force between the implant and the platform to incrementally reposition the spine. Where the spine has an abnormal curvature, the implant is installed on a vertebrae located at an apex of the abnormal curvature. In such a configuration the vertebrae may be manipulated to incrementally reposition the spine to remove the abnormal curvature. A torsional force may also be imparted on the vertebrae to incrementally reorient the spine.

In a preferred embodiment, installing the implant comprises boring a hole in a pedicle of the vertebrae, and threading a pedicle screw into the pedicle, the pedicle screw configured to rigidly couple the implant to the vertebrae.

In another aspect of the invention method is disclosed for performing a pectus excavatum procedure on a patient having a deformed sternum. The method comprises attaching a magnetically responsive implant to a location on the sternum, and positioning a chest plate exterior the patient's chest to generate a magnetic field, wherein the magnetic field effects an attractive force between the implant and the chest plate. The implant generally comprises a first magnet housed in a biocompatible casing.

The first magnet may be attached to a posterior surface on the sternum by incising a section of the patient's skin over the patient's sternum, separating the xiphoid process from the sternum, dissecting under the sternum and securing the first magnet to the posterior surface of the sternum. One method for securing the first magnet to the sternum comprises drilling a plurality of holes from an anterior location on the sternum to a posterior location on the sternum, and looping a plurality of sutures through the holes in the sternum and through a plurality of holes in the casing housing the first magnet.

According to yet another aspect of the invention, a method for incrementally repositioning a patient's sternum is disclosed. The method comprises installing a magnetically responsive implant to a location on the sternum, positioning a chest plate exterior the patient's chest to generate a magnetic field, wherein the magnetic field effects an attractive force between the implant and the chest plate, repositioning the patient's sternum to a first position as a result of the generated magnetic force, manipulating the magnetic field to one or more intermediate settings, repositioning the patient's sternum to one or more intermediate positions as a result of the attractive force generated by the one or more manipulated magnetic field settings, manipulating the magnetic field to a final setting, and repositioning the patient's sternum to a final position as a result of the attractive force generated by the final magnetic field setting.

According to a further aspect of the invention, an apparatus for incrementally manipulating an internal body member of a patient comprises a magnetically responsive implant adapted to be received on a location of the body member, the implant responsive to a magnetic field, and means for generating an attractive force between the implant and a platform external to the patient to manipulate the body member. The device may further comprise means for adjusting the magnitude and direction of the magnetic force applied between the platform and the implant. The device also has means for securing the implant to a location on the body member.

In a preferred embodiment, the apparatus has a means for detecting the force applied to the platform at a plurality of locations on the platform, such as a strain gauge. The strain gauge may also configured to measure the force at a plurality of locations on the platform.

According to yet another aspect of the invention, a method for incrementally repositioning an internal body member of a patient comprises installing a magnetically responsive implant to a location on the internal body member, positioning a platform exterior the patient to generate a magnetic field, the magnetic field effecting a magnetic force between the implant and the platform, measuring the magnetic force between the implant and the platform; adjusting the platform to tune the magnetic force applied between the implant and the platform; and manipulating the body member to a first state as a result of the generated magnetic force.

In an alternative embodiment of the present invention, an apparatus for manipulating one or more internal body members is disclosed. The apparatus comprises a first elongate member having a driving end and a receiving end, wherein the receiving end of the first member having a recess extending toward the driving end. The apparatus also has a second elongate member having a driving end and a receiving end, the receiving end of the second member having a recess extending toward the driving end. The second member is sized such that the receiving end of the second member is slideably received within the receiving end of the first member. The apparatus further comprises a first magnet coupled to the first member, and a second magnet coupled to the second member, wherein the first and second magnets are configured to repel each other such that an outward magnetic force is generated to the driving ends of the first and second members. The first and second magnets may be positioned within the recesses to change the magnitude of the force generated between the first and second magnets. The first and second magnets may also be configured such that rotation of the first magnet with respect to the second magnet changes the magnitude of the force generated between the first and second magnets.

According to another aspect of the invention, an apparatus for intermittently delivering a force to a body member to incrementally manipulate the body member comprises an implant adapted to be received on a location of the body member, the implant responsive to a magnetic field, a platform external to the patient, and a magnetic member coupled to the platform, wherein the magnetic member generates a magnetic force between the implant and the platform to incrementally manipulate the body member, the magnetic member and the implant configured such that rotation of the magnetic member varies the magnetic force between the implant and the platform.

Yet another aspect is a method for auto-anastomosing a region of the body. The method includes delivering a first magnetic member to a first location in the body adjacent the region, and locating a second magnetic member adjacent the region opposite from the first magnetic member, such that the region is disposed in between the first magnetic member and the second magnetic member. An attractive force is generated between the first magnetic member and the second magnetic member to compress tissue in the region between the first magnetic member and the second magnetic member. This compressive force results in necrosis of the tissue in the region between the first and second magnetic members such that the tissue surrounding the necrosed tissue heals together to form an anastomosis.

In a preferred embodiment of the present aspect, the method further includes removing the necrosed tissue and the first and second magnetic members from the region. Often, the necrosed tissue and the first and second magnetic members are removed from the region via flow of natural bodily functions. If need be, the first and second magnetic members may also be retrieved from a location at or near the region.

In another embodiment, the region comprises tissue occupied by first and second internal viscera segments in the body. The first magnetic member is delivered into the first viscera segment, and the second magnetic member is correspondingly delivered to the second viscera segment at a location in proximity to the first magnet to generate a compressive force on the tissue in between first and second viscera segments. Subsequently, the anastomosed region creates a fistula between the first and second viscera segments.

In some embodiments, the first viscera segment is located in a first viscera, and the second viscera segment is located in a location in a second viscera in proximity to the first viscera. Alternatively, the first viscera segment and second viscera segment are separate sections of the same viscera.

The viscera may be any hollow organ or lumen where anastomosis is desired. In a preferred embodiment, the method is performed on an organ or lumen, or plurality of organs or lumens, in the gastrointestinal or urinary tracts, such as the small intestines, stomach, colon, ureters, renal pelvis, bladder, urethra, etc.

In another embodiment, the treated region comprises tissue occupied by a visceral wall and surrounding tissue between the visceral wall and an external surface on the body. The first magnetic member is delivered to the visceral wall, and the second magnetic member is located adjacent the external surface in proximity to the first magnetic member to create a stoma between the internal visceral wall and the external surface.

Another aspect of the invention is a system for auto-anastomosing a region of the body. The system includes a first magnetic member configured to be delivered to a location in the body adjacent the region, and a second magnetic member configured to be located adjacent the region opposite from the first magnetic member such that the region is disposed in between the first magnetic member and the second magnetic member. The first and second magnetic members are configured to generate an attractive force to compress tissue in the region between them. The tissue in the region necroses as a result of the compressive force such that tissue surrounding the necrosed tissue heals together to form an anastomosis.

The system may further include a catheter that is configured to deliver the first magnetic member to the location adjacent the region and release the first magnetic member at the location.

In a preferred embodiment, the first magnetic member comprises a biocompatible casing, such as a titanium enclosure, or epoxy coating.

Yet another aspect is an apparatus for auto-anastomosing a region of the body comprising a first visceral wall. The apparatus comprises a first magnetic member configured to be delivered to a first location at the first visceral wall, the first location being adjacent the region, and a second magnetic member configured to be positioned at a second location adjacent the region opposite from the first magnetic member such that the region is disposed in between the first magnetic member and the second magnetic member. The first and second magnetic members are configured to generate an attractive force to compress and necrose the tissue in the region between them, such that tissue surrounding the necrosed tissue heals together to form a fistula from the first location to the second location.

In a preferred embodiment, the region further comprises tissue occupied by a second internal viscera wall in the body, and wherein the second magnetic member is configured to be delivered to the second visceral wall at a the second location to generate a compressive force on the tissue in the tissue in between first and second visceral walls.

Alternatively, the region comprises abdominal tissue in between the visceral wall and an external surface on the body, wherein the second magnetic member is configured to be positioned adjacent the external surface at the second location such that the fistula creates a stoma connecting the internal visceral wall to the external surface.

Additionally, the apparatus may also have an intermediate magnetic member configured to be positioned in the abdominal tissue between the first magnetic member and the second magnetic member to generate a compressive force between it and both the first magnetic member and the second magnetic member.

Further aspects of the invention will be brought out in the following portions of the specification, wherein the detailed description is for the purpose of fully disclosing preferred embodiments of the invention without placing limitations thereon.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

The invention will be more fully understood by reference to the following drawings which are for illustrative purposes only, and where like reference numbers denote like elements:

FIG. 1 is a schematic view of a human sternum with an implant according to the present invention installed under the sternum.

FIG. 2 is a cross-sectional schematic view of the platform of the present invention installed over a patient's chest and an implant installed under the sternum.

FIG. 3 shows an embodiment of the implant of the present invention.

FIG. 4 is a side view of the implant ofFIG. 3.

FIG. 5. is a schematic view of a sternum.

FIG. 6. is a cross-sectional view of a sternum with the xiphoid separated from the sternum body.

FIG. 7 is an implant drill guide according to the present invention.

FIG. 8 shows the drill guide ofFIG. 7 installed over the sternum.

FIG. 9 illustrates a preferred method for installing a portion of the implant to the posterior surface of the sternum.

FIG. 10 illustrates a portion of the drill guide ofFIG. 7 positioned over a second location on the sternum.

FIG. 11 illustrates a preferred method for installing a second portion of the implant to the posterior surface of the sternum.

FIG. 12 is another view of the method ofFIG. 11.

FIG. 13 shows the implant according to the present invention installed on the posterior surface of the sternum.

FIG. 14 is a view of the underside of an embodiment of the platform according to the present invention.

FIG. 15 is a view of the top of the platform ofFIG. 14.

FIG. 16 is a side view of another embodiment of the platform of the present invention.

FIG. 17 is a side of another embodiment of the platform of the present invention.

FIG. 18A is an anterior view of the human spine.

FIG. 18B is a lateral view of the human spine.

FIG. 19A-D illustrate various abnormal curvatures of the spine due to scoliosis.

FIG. 20 illustrates abnormal rotation of the vertebrae of the spine as a result of scoliosis.

FIG. 21 illustrates another embodiment of the invention for treating scoliosis.

FIG. 22 illustrates an alternative embodiment for delivering a pulsed magnetic field to a body member.

FIG. 23 is a schematic view of an alternative embodiment for delivering a repulsive force to a body member.

FIG. 24 is a schematic view of the device ofFIG. 23 with a fluid pump.

FIG. 25 illustrates an alternative embodiment of a repulsion device incorporating a mechanical jackscrew.

FIG. 26 illustrates an alternative embodiment of a repulsion device incorporating an electric jackscrew.

FIG. 27 is a schematic diagram for a system for performing auto-anstomosis between two internal organs using magnetic ring implants in accordance with the present invention.

FIG. 28 is a schematic diagram for a system for performing auto-anstomosis between two internal organs using magnetic disc implants.

FIG. 29 is another view of the system ofFIG. 27 showing the magnetic implants concentrically aligned.

FIG. 30 shows the system ofFIG. 27 with the magnets collapsing the visceral walls.

FIG. 31 is a view of the system shown inFIG. 27 with the tissue between the magnets cut out.

FIG. 32. illustrates the system ofFIG. 27 after the tissue between the magnets has necrosed and fallen out, with accompanying anastomosis and fistula.

FIG. 33 illustrates the system ofFIG. 27 after the magnets have fallen out of the fistula.

FIG. 34 illustrates an exemplary gastrointestinal tract.

FIG. 35 illustrates a patient with duodenal atresia.

FIG. 36 illustrates a schematic diagram of the system of the present invention used to treat the duodenal atresial.

FIG. 37 illustrates an exemplary urinary tract.

FIG. 38 shows a schematic diagram of a system for creating an ostomy using an internal magnet and external magnet in accordance with the present invention.

FIG. 39 illustrates a stoma in the abdominal wall created after implementation of the system ofFIG. 38.

FIG. 40 illustrates the system ofFIG. 38 using an intermediate internal magnet.

DETAILED DESCRIPTION OF THE INVENTION

Referring more specifically to the drawings, for illustrative purposes the present invention is embodied in the apparatus and methods generally shown inFIG. 1 throughFIG. 17 andFIGS. 21-26 and27-40. It will be appreciated that the apparatus may vary as to configuration and as to details of the parts, and that the methods may vary as to the specific steps and sequence, without departing from the basic concepts as disclosed herein.

The present invention utilizes a system in which a small magnet is implanted in cooperation with an internal body member to apply a corrective force to the body member by virtue of its attraction to an adjustable magnet in an external device that is comfortable and cosmetically pleasing.

Small rare earth metal magnets can produce considerable force and can be manipulated in terms of size, shape and position. This force can be used to alter growth and development of skeletal structure and soft tissue. The biology of tissue response to force has been well studied. Clinical application of this powerful biologic principle has been limited by the difficulties of applying force through external bracing or through internal pins manipulated by external devices (e.g., bone lengthening through distraction osteogenesis). Magnetic force fields can be used to apply force to implanted magnets attached to an internal structure without violating the skin and soft tissue. The magnetic force field can be manipulated externally to adjust the direction, strength and speed at which the deformity is corrected.

1. Pectus Excavetum

FIGS. 1-16 illustrate a preferred embodiment of the invention relating to the correction of pectus excavetum.FIG. 1 illustrates a schematic, anterior view of ahuman sternum20. Thesternum20 is an elongated, flatted bone, forming the middle portion of the anterior wall of the thorax. Thesternum20 generally consists of three parts: themanubrium22, which at its upper end supports the clavicles (not shown); the body orgladiolis24, which interfaces at its upper end with the lower end of themanubrium22, and thexiphoid process26, which interfaces at its upper end with the lower end of thegladiolis24 atjunction30. The margins ofsternum20 articulate with the first of seven pairs ofribs28.

As shown inFIG. 1 and illustrated as a cross-sectional view of a corrected patient's chest inFIG. 2, a magneticsubsternal implant42 may be installed on theposterior surface32 thebody24 of thesternum20, just above thexiphoid process26. Illustrated in greater detail inFIG. 3, theimplant42 preferably comprises arare earth magnet90, or an array of rare earth magnets housed incasing92. Thecasing92 may comprise any biocompatible material such as medical grade epoxy, titanium or suitable material used in the art.Casing92 preferably has mountingholes56 for fixation at each corner. Thecasing92 may also have a plurality ofprotrusions94 to enhance the attachment of theimplant42 with thesternum20.

Themagnetic implant42 is sized to fit comfortably behind the sternum. An exemplary implant may 3 inches long, 2½ inches wide and 3/16 thick. However, the size of the implant may vary according to patient anatomy.

FIG. 2 andFIGS. 5-13 illustrate an exemplary method of surgically installing theimplant42. A 3 cm substernaltransverse incision58 is made through the patient'sskin36. Theziphoid process26 is then separated from thelower sternum body24 and a pocket is bluntly dissected behind theposterior surface32 of the sternum, as illustrated inFIG. 6.

Theimplant42 is attached to the posterior surface of the sternum with sutury passed through theholes112 in the sternum illustrated inFIG. 2. Using laparoscopic or arthroscopic visualization, adrill guide100 is inserted and positioned over the proximal end of thesternum body24, as shown inFIGS. 7 and 8. A small stab wound is made intoskin36, and thedrill sleeve102 is inserted through theguide100. Thesternum20 is then drilled under direct visualization to bore one or moredistal bores106 from theanterior surface34 of the sternum through to theposterior surface32. Distal bores106 preferably line up with the corresponding mountingholes56 incasing92.

Referring now toFIG. 9, adistal suture108 is looped through one of the mount holes56 ofcasing92. Thedistal suture108 preferably comprises a heavy braided suture commonly used in the art,e.g. #2 or #5 ticron. The suture is then fed under thesternum20 and asuture retriever110, such as a Hewson type, is used to pull thedistal suture108 through the correspondingdistal bore106 in thesternum body24 and the anterior skin stab wound. The process is repeated for the second corner of the distal end of thecasing92.

Referring now toFIG. 10, theproximal end114 ofskin36 and subcutaneous tissues from the anterior sternum proximal to the sterno-xiphoid junction58 are pulled back to expose the proximal end of thesternum body24. Thedrill guide100 is moved transversely along thesternum body24 to the exposed portion of the sternum underproximal end114. Once sufficient exposure is obtained, one or moreproximal bores112 are drilled under direct vision through the sternum anteriorly-to-posteriorly, thus providing anchoring points for all corners of thecasing92.

Now referring toFIGS. 11 and 12, aproximal suture116 is looped through one of the mount holes56 on the proximal end ofcasing92. The suture is then fed under thesternum20 andsuture retriever110 is used to pull both ends of theproximal suture116 through the correspondingproximal bore112 in thesternum body24. The process is repeated for the second corner of the proximal end of thecasing92.

As seen inFIG. 12, both sets of proximal and

distal sutures

116,108 are pulled to guide theimplant42 up behind thesternum20 and maintain the apposition of thecasing92 to thesternum20 with traction on the sutures.

Referring now toFIG. 13, theproximal sutures116 are tied down firmly over the sternal bone bridge to secure theimplant20 to theproximal surface32 of the sternum. Under direct vision, the process is repeated for thedistal sutures108.

AlthoughFIGS. 9-13 illustrate a preferred embodiment using suture to fasten theimplant42 to thesternum20, it is appreciated that any number of different fastening means commonly known in the art may be used to secure theimplant42. For example, bolts (not shown) may be passed through

bores

106,112, threaded into threaded mountingholes56 ofcasing92 and torqued down to secure theimplant42 to theposterior surface32 of thesternum20. Alternatively, the implant may be fastened to either the posterior or anterior sides of the sternum via cables that wrap around the sternum. In this configuration, since the implant is closer to the platform, the internal magnetic member may be any magnetically responsive material, such as an iron plate with biocompatible coating (e.g. titanium).

Surgical placement generally requires a brief outpatient general anesthesia. The procedure takes about 30 minutes and requires minimal post-operative analgesia.

FIGS. 2 and 14-17 illustrate several embodiments of an external magnet platform of the present invention for treating pectus excavatum.FIGS. 14 and 15 show an embodiment having aplatform40 configured to be worn over a patient's chest.Platform40 comprises achest plate44 sized according to the patient's anatomy. Generally, a mold is made of the individual's chest deformity. From this the desired end point position of the sternum and chest wall shape are molded to create thechest plate44.FIG. 14 is a bottom view ofplatform40, showing theunderside78 ofchest plate44. In addition to being contoured to comfortably rest on the patient's chest, theunderside78 of the chest plate is cut away to createcavity68 that allows the chest to expand outward as a result of treatment.

In a first configuration, anexternal magnet48 is hung from theunderside78 of thechest plate44 by a plurality ofadjustment cables62.External magnet48 is preferably a rare earth magnet, or array of rare earth magnets. The external magnet has an adjustable stage, or mountingplate50, which has a plurality ofholes70 to securecables62. As illustrated inFIGS. 14 and 15, themagnet48 is hung with 4 cables. However, other configurations, such as a three cable design (not shown), may also be used. Thecables62 are coupled to the chest plate viaadjustment members54.Cables62 lead from themagnet plate50 out to theexterior surface46 and back through to the underside of the chest plate via throughholes64 to terminate atadjustment member54. One or more biasing springs52 may be imposed between thechest plate44 and themagnet48, creating a tensile force oncables62 so that the magnet is biased to the furthest orientation away from thechest plate44 that is allowed from the cables' length.

By turningadjustment member54 from the top of the chest plate illustrated inFIG. 15, thecable62 may be shortened, thereby advancing one corner of themagnet plate50 upward toward thechest plate44. By rotating the adjustment member in the opposite direction, the cable is extended, thereby advancing one corner of themagnet plate50 toward from the patient's chest and away from thechest plate44. When all the adjustment members are moved the same increment, the magnet will translate toward or away from the patient's chest in the Z axis (seeFIGS. 2 and 14). The magnet may also be rotated angle θ about the X or Y axis by manipulating theadjustment members54 to lengthen or shorten one ormore cables62 with respect to the remaining cables.

Theexternal magnet48 and theimplant magnet90 are configured so that their opposite poles face each other, thereby generating an attractive force between the two magnets. By manipulating the distance of theexternal magnet48 from thechest plate44 in the Z direction, the amount of force applied to the internal magnet can be incrementally tuned or adjusted. By manipulating the orientation of theexternal magnet48 with respect to thechest plate44 in the X and Y directions, the direction of force applied to the internal magnet can be incrementally adjusted.

Thechest plate44 is preferably comprised of a rigid material, such as a rigid thermoplastic or polymer or steel reinforced polymer that does not deform as a result of the magnetic forces, allowingexternal magnet48 to remain stationary with respect to the patient's chest. As a result of the constant force applied from theexternal magnet48, theimplant42 imposes a corrective outward force F on theposterior surface32 of thesternum20. This outward force incrementally repositions/deforms thesternum20 to move outward from the patient's chest cavity. By adjusting the angle of the external magnet in the X and Y directions, the force generated on theimplant42 may be directed to orient the sternum in the X and Y axes as well to correct asymmetric lesions.

An initial adjustment of the platform is made after the implant is placed in the outpatient surgical procedure. When thesternum20 andimplant42 move toward theexternal magnet48, the force generated between the magnets increases. If this force becomes too great and becomes uncomfortable for the patient, the magnet may be retracted toward thechest plate44, thereby returning the magnetic force to the optimum comfort level for the patient. This process may be repeated for a number of intermediary steps, until thesternum20 is gradually repositioned and/or deformed toward the desired final position and orientation.

Theplatform40 may also include astrain gauge74, or other force measuring means, to accurately determine the force being generated by the magnets.Strain gauge74 may be connected vialead wires76 to various points on themagnet plate50 so that the pressure on each quadrant of the magnet may be accurately assessed.Strain gauge74 may also comprise an LCD display (not shown) so that the patient or physician may readily assess whether theexternal magnet48 is properly oriented, and adjust the magnet if need be.

Theplatform40 is held in place by the magnetic pull between the two magnets, and in addition may be secured in place with a loose elastic band (not shown) around the chest. The principal force holding theplatform40 in place is the magnetic field itself. The patient may adjust theplatform40 to comfort and thus ensure against pressure damage to soft tissue. The patient may be taught to how to manipulate theexternal magnet48 up and down to adjust and balance the force pulling thesternum20 outward.

To provide extra comfort to the patient, and prevent the any unwanted manipulation of the adjustment members, a cover, such as that shown inFIG. 16, may be provided to cover the chest plate while the platform is being worn.

A preferred embodiment of the invention incorporating a bridgedplatform200 is illustrated inFIGS. 16 and 17.Platform200 has achest plate202 having asupport204 with opening206 at it center.Chest plate202 andsupport204 may be separate pieces fastened together as shown inFIG. 16, or one integrated piece (not shown).Load member208 is positioned in theopening206 ofsupport204, and is bridged by a plurality of thinbeam force sensors214.

Load member

208 has a plurality ofadjustment members210 that retainmagnet plate50 andmagnet48 via a hanging means212.Adjustment member210 comprises an in-line screw, such as a jack-screw, lead screw, ball screw, or the like, which is hollowed out to support hanging means212. As shown inFIGS. 16 and 17, hanging means212 comprises a ball chain, but may also comprise a cable, wire, or the like. Alternatively,adjustment members210 may comprise extended screws (not shown) that terminate a ball joint inmagnet plate50.

Adjustment members

210 may be manipulated to lower or raise themagnet48, or adjust the angle of the magnet, as described in the embodiment ofFIGS. 14 and 15. By turningscrew210 clockwise, one quadrant of theexternal magnet48 may be precisely lowered to change the angle of theexternal magnet48 with respect to the patient's chest, thereby changing the direction of the force applied to theimplant42. By turning all the screws the same clockwise increment, the magnet is lowered to generate a larger attractive force on the implant. Correspondingly, counter-clockwise rotation raises the external magnet to lower the attractive force on theimplant42.

When the platform is placed against the patient's chest, the attractive force between theimplant42 and the external magnet generates a load onload member208. This load is sensed at all four quadrants by the thinbeam force sensors214. Readings from thesensors214 are received by a force measuring means, such as thestrain gauge74 illustrated inFIG. 15, to provide accurate data on the force applied at each quadrant of the external magnet. This enables the treating physician or patient to accurately assess corrective the force being applied to the sternum, and modify the force if not at the desired level.

FIG. 17 illustrates an alternative embodiment having aplatform220 wherein the adjustment member comprises aclasp222 for incrementally adjusting the extended length ofball chain212, which is attached to each corner of theexternal magnet cradle224. By changing the position at which theclasp222 engages the ball chain212 (similar to adjusting a necklace of bracelet), the height at any one quadrant of themagnet48 may be changed with respect to the patient's chest to vary the force or direction of the corrective magnetic field.Chest plate202 andcradle204 may also have a layer ofpadding226 to provide further comfort for the patient.

Over time, the steady gradual force applied to the sternum stretches the ligaments connecting thesternum20 to the ribs. Thesternum20 itself may also deform as a result of the magnetic forces. The result is a reoriented and/or repositioned sternum without the characteristic depression of the pectus excavatum deformity.

As thesternum20 moves closer to theexternal magnet48, the patient or physician will typically readjust the position ofexternal magnet48 farther up into the chest plate. This is easily accomplished by adjusting the length of the four ball chains that suspend themagnet cradle224.

2. Scoliosis

FIGS. 18A and 18B illustrate the curvature of anormal spine300. The spine is relatively straight in thesagittal plane302 and has a double curve in thecoronal plane304. As shown below, thethoracic section308 of the spine is convex posteriorly and thelumbar section306 of the spine is convex anteriorly. Normally there should be no lateral curvature of the spine about thesaggital plane302.

Scoliosis is a deformity that generally comprises by both lateral curvature and vertebral rotation. FIGS.19A-D illustrate various forms of abnormal lateral curvature of the spine.FIG. 19A shows abnormalthoracic curvature310.FIG. 19B shows abnormalthoracolumbar curvature312.FIG. 19C shows abnormallumbar curvature314. Finally, some cases involve a double curvature of the spine, as shown inFIG. 19D shows abnormal thoracic curvature.

FIG. 20 illustrates rotation of the spine and corresponding effect on therib cage332 s a result of scoliosis. As the disease progresses, thevertebrae330 and spinous processes in the area of the major curve rotate toward the concavity of the curve. As the vertebral bodies rotate, the spinous processes deviate more and more to the concave side and the ribs follow the rotation of the vertebrae. The posterior ribs on theconvex side336 are pushed posteriorly, causing narrowing of the thoracic cage and the characteristic rib hump seen in thoracic scoliosis. The anterior ribs on theconcave side334 are pushed laterally and anteriorly.

Now referring toFIG. 21, a schematic view ofexternal platform350 is illustrated withimplant340 installed onvertebrae330 of the spine.Vertebrae330 is preferably located at the apex320 of the abnormal curvature shown in FIGS.19A-D. In apreferred embodiment implant340 is anchored tovertebrae330 via abone screw336.Screw336 may be threaded into abore334 in thepedicle332 of the vertebrae according to commonly used procedures for a variety of spinal conditions, including degenerative disc disease and scoliosis. Examples of such systems are disclosed in U.S. Pat. Nos. 6,648,915; 6,010,503; 5,946,760; 5,863,293; 4,653,481, etc., the entire disclosures of which are incorporated herein by reference.

Oncepedicle screw336 is installed,internal magnet342 may be fastened to screw336 viamagnet casing338 andnut346. Following the same procedure, a secondinternal magnet344 may also be installed on the pedicle on the opposite side ofimplant340.

After installation ofimplant340,external platform350 may be placed on the patient'sback366 adjacent to the installed implant. Platform may be retained to the torso of the patient by a strap the circles the patient's waist or chest at the elevation of the implantedvertebrae330.Platform350 comprises asupport352 that adjustably holds firstexternal magnet360. Firstexternal magnet360 is hung insiderecess364 by aplurality rods354, which are fastened toexternal mounting plate358

housing magnet

360. The angle and height ofmagnet360 may be incrementally adjusted byadjustment member356.

As illustrated inFIG. 21,external magnet360 andinternal magnet342 may be positioned with facing positive poles (or facing negative poles) to generate a repulsive force between theplatform350 and theimplant340. The resulting magnetic force creates a rotational moment R on thevertebrae330 to incrementally reorient thevertebrae330 and diminish the abnormal rotation angle β. Asvertebrae330 rotates to a more normal orientation, the rest of the vertebrae of the spine follow.

If a secondinternal magnet344 is installed oppositeinternal magnet342, a secondexternal magnet362 may be positioned oppositeinternal magnet344. As shown inFIG. 1, the opposing magnets may be positioned to generate an attractive force, thereby increasing the magnitude of the rotational moment R on the vertebrae.

In addition to effecting rotation of the spine,platform350 may be oriented to correct for lateral curvature of the spine. By placing theplatform350 to the line up to the left of the implants, as shown inFIG. 21, a translational force T is created on thevertebrae330 as a result of the attractive force between the secondexternal magnet362 and secondinternal magnet344. In this configuration,external magnet360 may be removed to increase the attractive force. Theplatform350 may be incrementally repositioned to continue translation of thevertebrae330.

3. Other Applications

Variations of the above embodiments could be use to gradually correct a variety of deformities. For example, pectus carinatum (a deformity of the chest involving a sternal protrusion) may be treated with the embodiments shown inFIGS. 14-17 and orienting the magnets to apply a repulsive rather than attractive force.

In another alternative embodiment, which may be beneficial for soft tissue deformities, a magnetic force discontinuously applied in order to accommodate blood flow to the tissue. For example, the force may be applied for a period of time (e.g. a minute) and then taken off for another period of time (applied in a pulsed fashion) in order to let blood flow back to the tissue being “reformed”. In one embodiment illustrated inFIG. 22, a pulsed force field is generated by rotation of theexternal magnet402 with respect to fixedinternal magnet402. The magnets may have magnetizedquadrants404 that repel/attract or become neutral upon a 90 degree rotation with respect to each other to achieve tension alternating with relaxation. In an alternative embodiment, the external magnet is moved closer and then farther from the internal magnet by rotating it on a cam (not shown).

In addition to magnetic force fields configured to manipulate body members by attraction of two magnets (e.g. the device above for repair of pectus excavatum), the magnets may be configured to provide a repulsive force (e.g. a magnetic Elizeroff to lengthen bone). In the embodiment illustrated inFIG. 23,internal repulsion device410 comprisesfirst member414 partially encased insecond member412, whereinfirst member414 is allowed to slide insidesecond member412. Each member has a corresponding

internal magnet

416,418 which are configured to repel each other, thus forcingfirst member414 to separate fromsecond member412 to form a “magnetic spring” to distance anatomy located on ends420 and422. The repulsive force may be varied by adjusting the position of

magnets

418 and416 away from ends420 and422.

Repulsion device

410 may be used in a variety of applications where gradual force may be applied to reposition or deform one or more body members. For example,device410 may be disposed such that ends420 and422 are attached to two separate locations of a bone to lengthen or alter the shape of the bone.

In an alternative embodiment illustrated inFIG. 24,repulsion device430 may be used havingreservoir434 and pump436. Pump436 may be positioned underneath the patient'sskin438, such that fluid may be directed throughlead line440 toreservoir434 insecond chamber432. The pump may be used to increase the volume ofreservoir434, thereby distancingmagnet416 away fromend420 to incrementally increase the repulsive force between416 and418.

In another alternative embodiment illustrated inFIG. 25,repulsion device450 comprises amechanical jackscrew470. The device has afirst member452 andsecond member454 that apply a repulsive force to attachment points456 and458 that may be attached to one or more body members.Rotary magnet coupling468 has aninternal magnet474 under the patient'sskin476 and a correspondingexternal magnet472.

The magnets are polarized such that rotation of theexternal magnet472 causes a proportional rotation inexternal magnet474, which in turn rotatesflexible shaft478. Rotation offlexible shaft478 is transferred to rotation ofscrew462 located onfirst member452 viaworm gear460.Nut466 is attached tosecond member454 and is threaded to screw462 such that rotation ofscrew462 causes thefirst member452 to separate from454. Additional force and separation may be achieved by further rotation ofexternal magnet474.Springs464 may optionally be employed to create an additional preload between the first and second members.

FIG. 26 illustrates another alternative embodiment of arepulsion device500 having an electric jackscrew.Control box504 controls rotation ofmagnetic coupling502. A signal is sent viawire510 toelectronics512 to controlelectric motor514, which drives rotation ofscrew518 throughgear reduction516. Thus, a repulsive force may be incrementally applied to separatefirst member524 fromsecond member522.

4. Fistula and Auto-Anastomosis

In many situations, it is desirable to have two segments of hollow viscera to be brought in continuity by creating a fistula between them. Stategic placement of magnets in accordance with the present invention may be used to create an auto-anastomosis, essentially a fistula, in a minimally invasive way.

The method of the present invention for performing an auto-anastomosis or a fistula would be to have one magnet in each of the two hollow viscera and let them collapse. Because the strength of attraction between the two magnets increases the closer they are together, the magnets can apply enough force over time to cause necrosis of the tissue between. If the timing is correct, the tissue just outside the crushed tissue will essentially heal together, creating a fistula. The magnet pair would then fall out into the lumen and could be retrieved or passed.

Referring toFIG. 27, a method andsystem800 for performing a side-to-side anastomosis in two hollow viscera is described. According the method of the present invention, a firstmagnetic implant802 is positioned in afirst organ segment806 at a region or location where anastomosis and fistula is desired.

Delivery of the magnet to the desired location in the body may be facilitated through open surgery or through a number of minimally invasive approaches. For example, standard techniques such as laparoscopy, thorascopy, fetoscopy and the like may be employed, depending on the desired location and/or procedure. In some procedures, delivery may be achieved without open surgery, e.g. via gastrointestinal or urinary tract endoscopy.

FIG. 27 illustrates delivery to a location inorgan segment806 by use of acatheter830.Catheter830 may have a variety of configurations currently available in the art for delivery of an implant or other device through a lumen. For example,catheter830 may have acatheter tube834 housing remotelyretractable grippers832. Thegrippers832 may hold themagnet802 insideretractable sheath836 while thecatheter830 is delivered to the desired location in the lumen. Thesheath836 may then be retracted to allow themagnet802 to be released at the location.

After placement of the first magnet, secondmagnetic implant804 is delivered to asecond organ section808 in proximity tofirst section806. It is appreciated thatorgan segments806/808 may be separate locations in the same organ, such as two sections of bowel that are separated by an obstruction or atresia, or separate but adjacent organs, such as between a ureter and bladder, or arterial-venous fistula.

As shown inFIG. 27,

implants

802 and804 are generally ring-shaped having a centrally locatedaperture810. Alternatively,

implants

812 and814, shown inFIG. 28, may be used that are disc shaped.

Implants

812 and814 may be used in situations where an obstruction can be temporarily tolerated until the fistula is created (explained in more detail below). The implants are generally comprised of a magnetically charged material. A coating or hermetically sealed casing, such as titanium or epoxy, may encapsulate the implants to ensure biocompatibility. The outside diameter d_oof the implant may vary according to the size of the desired fistula. Accordingly, the inside diameter d_imay vary depending on the size of the temporary passage (described in further detail below). It is also appreciated that the implant may be configured to have one of a number of shapes depending on the application, e.g. the outer and inner edges may be elliptical, or other shape to accommodate the desired fistula.

Referring now toFIG. 29, the

implants

802,804 are placed with opposite poles facing each other at the desired location for the fistula. This creates an attractive force between the

magnets

802 and804, and the

interior walls

816 and818 between the magnets. The attractive force also acts to concentrically align

magnets

802 and804 along the same axis.

As illustrated inFIG. 30, the attractive force of the

magnets

802 and804 draws the

inner walls

816 and818 together until they contact each other. A compressive force is generated on thetissue820 of

walls

816 and818 between the magnets. This compressive force gradually increases as the magnets get closure to each other.

Referring now toFIG. 31 In situations where a temporary passage for the contents of the viscera is desired or required (e.g. an obstruction downstream from the implant location) acutout822 may be performed in thetissue820 of

walls

816 and818. The cutout may be circular to generally match the shape of hole819 of the magnets. As shown inFIG. 31,cutout822 andholes810 in the magnets all flow F of the contents of the viscera to be immediately restored to essentially bypass any downstream obstruction.Cutout822 may be made non-invasively via a cutting tool (not shown) disposed at the location via and catheter830 (shown inFIG. 27).

Alternatively, disc-shaped

magnets

812 and814 may be used where obstruction (or other condition) of the viscera is tolerable for the period it takes to achieve auto-anastomosis. In this case, no cutout is made inwalls820.

In either case, the compressive force placed on thetissue820 trapped between the magnets causes necrosis of thetissue820. As shown inFIG. 32, the tissue eventually falls out over a period of time (usually within days), and the

walls

816 and818 heal, or fuse together to form afistula826 around the perimeter of themagnets802/804.

Finally inFIG. 33, themagnets802/804 and necrosed tissue between them (if any), fall out from thefistula826 and may either be retrieved, or simply pass out of the patient's system through the newly anastamosed lumen.

The above described method and system for auto-anastomosis may be performed on any hollow viscera, lumen, organ, etc. in the body where anastomosis and/or fistula are conventionally performed. For example thesystem800 may be used for side-to-side anastomosis in the vascular system, e.g. an arterial-venous fistula for vascular access.

However, the methods andsystem800 are ideally suited in regions of the body that are more susceptible to necrosis under high pressure, such as the gastrointestinal and urinary tracts.

Referring toFIG. 34 of the gastrointestinal tract, thesystem800 may be used to achieve anastomosis in theesophagus840, down to thestomach842,small intestine846 andcolon848. For example, the anastomosis may be performed in bariatric procedures such as gastric bypass.

In addition,system800 may be used for palliative procedures for bowel stenosis or obstruction, i.e. intestinal atresia. Intestinal atresia may aoocur in a number of places in the gastrointestinal tract, e.g. theduodenum844,jejunum850 andileum852 of thesmall intestine846, andcolon848. An anastomosis/fistula may be readily performed in this regions given the characteristics of the bowel, and the ease of placing segments of these organs adjacent to each other to bypass an obstruction. In certain types of jejunoileal atresia, where significant portions of the small intestine are missing, the present invention may be configured to stretch the separated intestinal lumens prior to anastomosis, similar to the system disclosed in co-pending U.S. application Ser. No. 11/222,517, incorporated herein by reference in its entirety.

FIG. 35 illustrates a schematic diagram of a patient having duodenal atresia. Theduodenum844 has ablockage858 separating anupper portion854 from alower portion856 of the duodenum.

Referring now toFIG. 36,

magnetic implants

802 and804 are delivered separately to each side of the blockage oratresia858. This may be achieved via separate catheters, similar tocatheter assembly830, into the adjacent regions. For example,magnet802 may be delivered via a catheter through the mouth and esophagus, or via laparoscopy.Magnet804 may also be delivered via laparoscopy, or via endoscope. The magnets are positioned, and thesegments854 and/or856 are maneuvered so that the magnets align adjacent to each other across the tissue of each segment. The autoanstomosis process, as depicted inFIGS. 30-33, occurs over a period of time until a fistula is achieved and the magnets dislodge to be retrieved or pass out of the system.

Referring now toFIG. 37,system800 may also be implemented to perform an anastomosis/fistula in the organs of the urinary tract, includingurethra866,bladder864, andureters860. For example,

implants

802 and804 may be delivered to appropriate locations to create a fistula between a ureter and the bladder, or in therenal pelvis870.

Referring now toFIGS. 38-39,system880 may be implemented to create an ostomy. As shown inFIG. 38, amagnetic implant882 may be delivered to a desired location in theorgan886 to be treated, e.g. the colon for a colostomy, small intestine for an illeostomy, or ureter for a urostomy. Theimplant882 may be delivered viacatheter830 either by endoscope or laparoscope. Anexternal magnet884 is then placed over the patient'sskin888 adjacent theinternal magnet882, with opposite polarities facing each other so that an attractive force is generated between the magnets.

The attractive force between

magnets

882 and884 generate a compressive force on the tissue in between them, e.g.visceral wall894,abdominal wall890, andskin888. This compressive force causes the tissues to necrose, and eventually anastomose until the magnets and tissue fall out, creating a fistula andstoma892 through the visceral wall, abdominal wall and skin, as illustrated inFIG. 39. A plastic pouch, e.g. colostomy bag, is then attached to theskin888 aroundstoma892.

As shown inFIG. 40, the system may also include one or more intermediateinternal magnets896 to better facilitate necrosis of theabdominal wall890. For example, thefirst implant882 may be inserted into the desiredorgan886, and asecond implant896 may be implanted in the abdominal wall between theskin888 and visceral wall8894. The polarities of

magnets

882,894 and884 are aligned so that all three magnets attract toward each other. This has the effect of shortening the distance between magnets, thereby increasing the compressive force between them to facilitate necrosis and auto-anastomosis. Two or more intermediate internal magnets may also be used where necessary.

All magnetic members or implants heretofore disclosed may have magnetic, ferromagnetic, or electromagnetic properties and may include one or more materials, e.g. magnetic or non-magnetic

Therefore, it will be appreciated that the scope of the present invention fully encompasses other embodiments which may become obvious to those skilled in the art, and that the scope of the present invention is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.” All structural, chemical, and functional equivalents to the elements of the above-described preferred embodiment that are known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Moreover, it is not necessary for a device or method to address each and every problem sought to be solved by the present invention, for it to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed under the provisions of 35 U.S.C. 112, sixth paragraph, unless the element is expressly recited using the phrase “means for.”

Claims

1. A method for auto-anastomosing a region of the body, comprising:

delivering a first magnetic member to a first location in the body adjacent said region;

locating a second magnetic member adjacent said region opposite from said first magnetic member such that said region is disposed in between said first magnetic member and said second magnetic member;

generating an attractive force between said first magnetic member and said second magnetic member to compress tissue in said region between the first magnetic member and said second magnetic member; and

necrosing said tissue in said region as a result of said compressive force;

wherein tissue surrounding said necrosed tissue heals together to form an anastomosis.

2. A method as recited inclaim 1, further comprising:

removing said necrosed tissue and said first and second magnetic members from said region.

3. A method as recited inclaim 2, wherein said necrosed tissue and said first and second magnetic members are removed from said region via flow of natural bodily functions.

4. A method as recited inclaim 2, said first and second magnetic members are retrieved from a location at or near said region.

5. A method as recited inclaim 1:

wherein said region comprises tissue occupied by first and second internal viscera segments in the body;

wherein said first magnetic member is delivered into said first viscera segment, and

wherein said second magnetic member is delivered to said second viscera segment at a location in proximity to said first magnet to generate a compressive force on the tissue in between first and second viscera segments.

6. A method as recited inclaim 5, wherein the anastomosed region creates a fistula between the first and second viscera segments.

7. A method as recited inclaim 6, wherein the first viscera segment is located a first viscera, and the second viscera segment is located in a second viscera in proximity to said first viscera.

8. A method as recited inclaim 6, wherein the first viscera segment and the second viscera segment are separate sections of the same viscera.

9. A method as recited inclaim 2:

wherein said region comprises tissue occupied by a visceral wall and surrounding tissue between said visceral wall and an external surface on the body;

wherein said first magnetic member is delivered to said visceral wall,

wherein said second magnetic member is located adjacent said external surface in proximity to said first magnetic member, and

wherein said anastomosed region creates a stoma between said visceral wall and said external surface.

10. A method as recited inclaim 1, wherein said region comprises tissue of an organ in the gastrointestinal or urinary tract.

11. A method as recited inclaim 1, wherein said first magnetic member is delivered to said region via a catheter.

12. A system for auto-anastomosing a region of the body, comprising:

a first magnetic member configured to be delivered to a location in the body adjacent said region;

a second magnetic member configured to be located adjacent said region opposite from said first magnetic member such that said region is disposed in between said first magnetic member and said second magnetic member;

wherein said first and second magnetic members are configured to generate an attractive force to compress tissue in said region between them; and

wherein said tissue in said region necroses as a result of said compressive force such that tissue surrounding said necrosed tissue heals together to form an anastomosis.

13. A system as recited inclaim 12, wherein said first and second magnetic members are configured to fall away or be retrieved from said region.

14. A system as recited inclaim 12:

wherein said region comprises tissue occupied by first and second viscera segments in the body;

wherein said first magnetic member is configured to be delivered into said first viscera segment; and

wherein said second magnetic member is configured to be delivered to said second viscera segment at a location in proximity to said first magnet to generate a compressive force on the tissue in the tissue in between first and second viscera segments.

15. A system as recited inclaim 13:

wherein said first magnetic member is configured to be delivered to said visceral wall;

wherein said second magnetic member is configured to be located adjacent said external surface in proximity to said first magnetic member;

16. A system as recited inclaim 12, further comprising:

a catheter configured to deliver said first magnetic member to said location adjacent said region and release said first magnetic member at said location.

17. A system as recited inclaim 12, wherein first magnetic member is configured to be delivered to an organ in the gastrointestinal or urinary tract.

18. A system as recited inclaim 12, wherein said first magnetic member comprises a biocompatible casing.

20. An apparatus for auto-anastomosing a region of the body, said region comprising a first visceral wall, comprising:

a first magnetic member configured to be delivered to a first location at the first visceral wall, said first location being adjacent said region;

a second magnetic member configured to be positioned at a second location adjacent said region opposite from said first magnetic member such that said region is disposed in between said first magnetic member and said second magnetic member;

wherein said tissue in said region necroses as a result of said compressive force such that tissue surrounding said necrosed tissue heals together to form a fistula from said first location to said second location.

21. An apparatus as recited inclaim 20, wherein said first and second magnetic members are configured to fall away or be retrieved from said fistula.

22. An apparatus as recited inclaim 20:

wherein said region further comprises tissue occupied by a second visceral wall in the body;

wherein said second magnetic member is configured to be delivered to said second visceral wall at a said second location to generate a compressive force on the tissue in the tissue in between first and second visceral walls.

23. An apparatus as recited inclaim 21:

wherein said region further comprises abdominal tissue in between said visceral wall and an external surface on the body;

wherein said second magnetic member is configured to be positioned adjacent said external surface at said second location;

wherein said fistula creates a stoma connecting said visceral wall to said external surface.

24. An apparatus as recited inclaim 23, further comprising:

an intermediate magnetic member configured to be positioned in the abdominal tissue between the first magnetic member and the second magnetic member;

the intermediate magnet configured to generate a compressive force between it and both the first magnetic member and the second magnetic member.

25. An apparatus as recited inclaim 24, further comprising:

a catheter configured to deliver said first magnetic member to said location adjacent said region;

wherein said catheter is further configured to release said first magnetic member at said location.

26. An apparatus as recited inclaim 25, wherein first magnetic member is configured to be delivered to an organ in the gastrointestinal or urinary tract.